MAUDE Adverse Event Report: K2M, INC. TAB REMOVAL TOOL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	5101-90195
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that an everest xt tab removal tool handle fractured during surgery.The procedure was successfully completed with no surgical delay.There was no adverse consequence to the patient.
Additional Manufacturer Narrative
Stryker initiated a voluntary recall on (b)(6) 2020 and an urgent medical device recall letter was sent to the affected customers notifying them of the product issue and associated risks and providing instructions pertaining to the removal and return of the product to stryker.
Event or Problem Description
A physician reported that an everest xt tab removal tool handle fractured during surgery.The procedure was successfully completed with no surgical delay.There was no adverse consequence to the patient.
Additional Manufacturer Narrative
Visual inspection of the returned device confirmed that the handle was fractured.Device history records were reviewed for this lot and no relevant manufacturing issues were identified.Complaint history was reviewed and 6 similar complaints for this lot were identified.A non-conformance was initiated to investigate the root cause associated with this failure mode.The investigation revealed loctite®, a threadlocker applied at the internal threaded interface between the metal shaft and radel® plastic handle, seeped beyond the threads (preventing adequate curing) and reacted with the radel® material.This resulted in the handle cracking and/or separating and, in some instances, leakage of loctite® from handle cracks.Stryker initiated a voluntary recall on 20 october 2020 and an urgent medical device recall letter was sent to the affected customers notifying them of the product issue and associated risks and providing instructions pertaining to the removal and return of the product to stryker.
Event or Problem Description
A physician reported that an everest xt tab removal tool handle fractured during surgery.The procedure was successfully completed with no surgical delay.There was no adverse consequence to the patient.

• Brand Name: TAB REMOVAL TOOL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10708046
• Report Number: 3004774118-2020-00267
• Device Sequence Number: 14392957
• Product Code: LXH
• UDI-Device Identifier: 10888857290679
• UDI-Public: 10888857290679
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5101-90195
• Device Lot Number: MAJR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 10/20/2020; 12/17/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 11/18/2020; 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 86733
• Patient Sequence Number: 1